Standardized Quality Control (for research use only)

While the number of Biobanks worldwide is growing rapidly, quality control of the whole process Is a requirement to ensure the value of the biobanks. Standardization is needed to allow researchers to integrate results obtained of specimen tests from 1 or more biobanks.

Standardization also includes the QC Process, which needs to cover all aspects of pre-analytics and sample storage. In addi- tion validation of specimen/donor metaparameters is of addi- tional value. NMR is especially suited to perform QC-analysis of liquid biopsies and can deliver a large number of criteria based on one QC measurement per sample.

In addition to QC Information NMR can deliver a large number of metabolic information using the same spectra generated during the QC process. With this information in urine 150 metabolites in 2 age ranges are quantified. In plasma/serum 115 lipoprotein related parameters (including subclasses) and 26 metabolites/parameters are analyzed and quantified, the whole process is under push button automation and can be handled by a trained medical technical assistant.

Example BioBank QC Summary

Extract of the summary page of the B.I.BioBankQC-PS and B.I.BioBankQC-UR report.

IVDR Platform and Its Embedded Solutions

Rich Spectral Information

Based on the outstanding performance of NMR in reproducibility and transferability, high quality analysis of data is available to deliver additional information for the biobank specimens. Together with the biobank, tool packages are offered for plasma/serum and urine quantification as outlined before. A multitude of disease relevant as well as endog- enous metabolites and lipoprotein information is delivered extracted from the QC spectra analysis.

Standardized Reporting

Example of the QC report available from B.I.BioBankTool

Spectra Instead of Aliquots

Based on the IVDr Platform concept and its strict standardiza- tion for NMR data generation, it is possible to select spectra from multiple biobanks for large epidemiological studies on a worldwide basis or to expand the testing range of clinical trials, providing for example spectra from healthy cohorts out of the biobanks Instead of generating always new aliquots. This builds a new value proposition for biobanks, allowing to save cost and contribute to big data in an efficient way. New NMR based diagnostic tests can such be validated on a worldwide basis and multiple phenotypes without exploding the cost of the trial. Data generated from a 11 IVDr platform ringtest clearly proof this unique feature of NMR.